Linezolid

LINEZOLID- linezolid powder, for suspension
Hikma Pharmaceuticals USA Inc.

1 INDICATIONS AND USAGE

1.1 Nosocomial Pneumonia

Linezolid is indicated for the treatment of nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae [see Clinical Studies (14) ].

1.2 Community-acquired Pneumonia

Linezolid is indicated for the treatment of community-acquired pneumonia caused by Streptococcus pneumoniae , including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible isolates only) [see Clinical Studies ( 14)].

1.3 Complicated Skin and Skin Structure Infections

Linezolid is indicated for the treatment of complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus pyogenes , or Streptococcus agalactiae. Linezolid has not been studied in the treatment of decubitus ulcers [see Clinical Studies (14) ].

1.4 Uncomplicated Skin and Skin Structure Infections

Linezolid is indicated for the treatment of uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes [see Clinical Studies ( 14)].

1.5 Vancomycin-resistant Enterococcus faecium Infections

Linezolid is indicated for the treatment of vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia [see Clinical Studies (14) ].

1.6 Limitations of Use

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Linezolid is not indicated for the treatment of Gram-negative infections. It is critical that specific Gram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected [see Warnings and Precautions (5.4) ].

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The safety and efficacy of linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials [see Clinical Studies (14) ].

1.7 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid and other antibacterial drugs, linezolid should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

2 DOSAGE AND ADMINISTRATION

2.1 General Dosage and Administration

The recommended dosage for linezolid formulations for the treatment of infections is described in Table 1.

Table 1. Dosage Guidelines for Linezolid

* Due to the designated pathogens [see Indications and Usage (1)]. † Neonates less than 7 days: Most pre-term neonates less than 7 days of age (gestational age less than 34 weeks) have lower systemic linezolid clearance values and larger AUC values than many full-term neonates and older infants. These neonates should be initiated with a dosing regimen of 10 mg/kg every 12 hours. Consideration may be given to the use of 10 mg/kg every 8 hours regimen in neonates with a sub-optimal clinical response. All neonatal patients should receive 10 mg/kg every 8 hours by 7 days of life [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)]. ‡ Oral dosing using either linezolid tablets or Linezolid for Oral Suspension [see How Supplied/Storage and Handling (16)].
Infection *	Dosage, Route, and Frequency of Administration		Recommended Durationof Treatment(Consecutive Days)
	Pediatric Patients † (Birth through 11 Years of Age)	Adults and Adolescents (12 Years and Older)
Nosocomial pneumonia	10 mg/kgintravenously or oral ‡every 8 hours	600 mgintravenously or oral ‡every 12 hours	10 to 14
Community-acquired pneumonia, including concurrent bacteremia
Complicated skin and skin structure infections
Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia	10 mg/kgintravenously or oral ‡every 8 hours	600 mgintravenously or oral ‡every 12 hours	14 to 28
Uncomplicated skin and skin structure infections	Less than 5 yrs:10 mg/kg oral ‡every 8 hours 5 to 11 yrs:10 mg/kg oral ‡every 12 hours	Adults:400 mg oral ‡every 12 hours Adolescents:600 mg oral ‡every 12 hours	10 to 14

No dose adjustment is necessary when switching from intravenous to oral administration.

2.5 Constitution of Oral Suspension

Linezolid for Oral Suspension is supplied as a powder for constitution. Gently tap bottle to loosen powder. Add a total of 123 mL distilled water in two portions. After adding the first half, shake vigorously to wet all of the powder. Then add the second half of the water and shake vigorously to obtain a uniform suspension. After constitution, each 5 mL of the suspension contains 100 mg of linezolid. Before using, gently mix by inverting the bottle 3 to 5 times. Do not shake. Store constituted suspension at room temperature. Use within 21 days after constitution.